- Abbott (St. Paul, MN)
- …catheters and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Regulatory Affairs Project Manager ** position is an ... the Abbott Vascular Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific,… more
- Teleflex (Maple Grove, MN)
- …a difference in patients' lives. **Position Summary** Under the guidance of the Manager , Strategic Regulatory Affairs , support the Strategic Manufacturing ... Regulatory Affairs Specialist **Date:** Jan 10,... requirements for the strategic manufacturing projects to the project managers and program manager . * Ensure… more
- Sumitomo Pharma (St. Paul, MN)
- …a dynamic, highly motivated, and experienced individual for the position of **Senior Clinical Project Manager , Medical Affair.** The Senior Clinical Project ... + Presents IIS/Collaborative Research/Expanded Access program status at applicable Medical Affairs meetings + Confirms completion of all deliverables per study… more
- Medtronic (Minneapolis, MN)
- …Minimum Requirements + Requires a Baccalaureate degree + Minimum of 4 years of regulatory affairs experience or advanced degree with a minimum of 2 years ... compassionate world. **A Day in the Life** The Sr. Regulatory Specialist will provide both pre-market and post-market ...agencies (eg, FDA and TUV), and working with cross-functional project teams. + In depth experience with FDA requirements,… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …own, and drive the global IT strategy for the assigned Quality Assurance and Regulatory Affairs (QARA) business domains in alignment with the overall strategy ... Insight and Analytics, and Infrastructure & Service Delivery teams. After project completion, establish a learning & improvement review process to continuously… more
- Sumitomo Pharma (St. Paul, MN)
- …a dynamic, highly motivated, and experienced individual for the position of **Senior Manager , Medical Affairs Technology and Digital Innovation** . **Job Duties ... Supports the development, implementation, execution, and oversight of Medical Information/Medical Affairs digital services and innovative digital projects as well as… more
- Omnicell (Minneapolis, MN)
- … Regulatory Specialist II (Quality Assurance Engineer II)** Reporting to the Manager of Product Regulatory and located at the Omnicell Cranberry Woods, ... Worth, TX facility, or based remotely, the Quality and Regulatory Engineer will be responsible for supporting product ...proficiency with common MS office programs (Word, Excel, PowerPoint, Project ) + Ability to work under tight deadlines and… more
- Danaher Corporation (New Brighton, MN)
- …diagnostic tools that address the world's biggest health challenges. The Sr. Clinical Affairs Manager is responsible for directly managing a team driving ... This position is part of the Clinical & Medical Affairs department, of which the EU Hub is located...regulatory requirements + Drive clinical schedule deliverables and project financial forecasts to meet the overall project… more
- GAF (Minneapolis, MN)
- …And under this roof, we protect what matters most. **Job Summary** The Corporate Public Affairs Manager position works with the plant manager and leadership ... support customer engagement in strategic community activities and engagements + Regulatory compliance: Understand all key regulatory requirements for… more
- Takeda Pharmaceuticals (St. Paul, MN)
- …groups to liaise effectively with cross-functional team members (Program Management, Global Regulatory Affairs , Regulatory Operations, Drug Discovery Units, ... NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs , Regulatory Operations) to plan, generate,… more
- Takeda Pharmaceuticals (St. Paul, MN)
- …and EU standards and guidelines. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team to ensure that ... represented at the Labeling cross functional teams including clinical, safety, medical affairs , device regulatory and commercial, to ensure highly effective… more
- Danaher Corporation (New Brighton, MN)
- …regular study progress communication and escalating issues. This position reports to the Sr. Manager or Director of Clinical Affairs and is part of the Clinical ... (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Clinical Study Manager at Radiometer is responsible for overseeing all aspects… more
- Danaher Corporation (Chaska, MN)
- …a part of the Data Management Team and report to the Senior Staff Data Manager responsible for supporting data management project needs and activities to ensure ... the world's biggest health challenges. The Senior Clinical Data Manager for Beckman Coulter Diagnostics is responsible for technical...FDA requirements. This position is part of the Clinical Affairs organization and will be an onsite position in… more
- Teleflex (Maple Grove, MN)
- …Marketing * Project Management Office * Clinicians * Quality / Design Assurance * Regulatory Affairs * Clinical & Medical Affairs * Legal * Finance * ... Global Product Manager **Date:** Jan 15, 2025 **Location:** Maple Grove,...establish clear geographic scope and ensure projects meet regional regulatory and technical requirements * Execute marketing deliverables for… more
- Fujifilm (St. Paul, MN)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... **Position Overview** The Product Manager is a member of the HCUS/MIPD Solution...but are not limited to: + Creation of: + Project Charters. + Market Requirements Definition (MRD). + Product… more
- Danaher Corporation (Chaska, MN)
- …used by engineering team + Act as a partner between Product Management, Regulatory Affairs , Quality Assurance, Commercial, Operations, and R&D teams. The ... the support you need to be successful. The Sr. Manager , Electrical and Systems Engineering for Beckman Coulter is...Electrical Engineering Team + Develop resource, budget plans and project roadmaps in conjunction with other business leaders to… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA) ... Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company....process as required as a CAPA Lead or CAPA project team member. + As requested by Market Quality… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA) ... Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company....the CAPA process as required as an assignee or project team member. + Investigates escalated product complaints to… more
- Edwards Lifesciences (St. Paul, MN)
- …Biostatistician** (Individual Contributor/ Subject Matter Expert) or the **Senior Manager , Biostatistics** (Statistical Lead/ People Manager ) Imagine how ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA) ... Drive the design & execution of Production Release Process project for components & finished devices + Lead and...of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO… more